A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Arm 1: PF-05221304 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
研究概览
简要总结
Drug drug interaction study between PF-05221304 and PF-06865571
详细描述
A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Effect of PF-05221304 on PF-06865571 PK
干预措施: PF-06865571 administered Day 7-14 (Drug)
Effect of PF-05221304 on PF-06865571 PK
干预措施: PF-05221304 administered Day 1-14 (Drug)
Effect of PF-06865571 on PF-05221304 PK
干预措施: PF-06865571 administered Day 1-14 (Drug)
Effect of PF-06865571 on PF-05221304 PK
干预措施: PF-05221304 administered Day 7-14 (Drug)
结局指标
主要结局
Arm 1: PF-05221304 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
时间窗: Day 7, 0-12 hours and Day 14 0-12 hours
Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
Arm 2: PF-06865571 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
时间窗: Day 7, 0-12 hours and Day 14 0-12 hours
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.
Arm 2: PF-06865571 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
时间窗: Day 7, 0-12 hours and Day 14 0-12 hours
Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
Arm 1: PF-05221304 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
时间窗: Day 7, 0-12 hours and Day 14 0-12 hours
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)(Screening up to 28 days after last dose of study medication)